Each year in the United States over 100 million patients acquire scars, some of which cause considerable medical and psychological problems. People with abnormal skin scarring may face physical, aesthetic, psychological and social consequences that may be associated with substantial emotional and financial costs.
Scars arise after almost every dermal injury—rare exceptions include tattoos, superficial scratches, and venepunctures. While some scars are considered medically trivial, they can be disfiguring, aesthetically unpleasant and cause severe itching, tenderness, pain, sleep disturbance, anxiety, depression and disruption of daily activities. Other psychosocial sequelae include development of post-traumatic stress reactions, loss of self-esteem and stigmatization, all leading to a diminished quality of life.
While there is considerable quantitative and qualitative variation in scarring potential between individuals, it is known that topical treatments can greatly reduce the appearance of scaring in a broad spectrum of scar types, ranging from fine line scars to a variety of abnormal scars, such as atrophic scars, scar contractures, hypertrophic scars and keloid scars.
While treatments may vary from non-invasive treatment, invasive treatment, to leave alone management, the most cost effective means when compared with results has traditionally been non-invasive treatments such as compression therapy, static and dynamic splints, acrylic casts, masks and clips, application of a variety of oils, lotions, and creams (e.g., “topicals”), the latter being the most widespread and having the most significant long term benefits.
These topicals do not just treat scars however, but are used to treat a wide range of dermatological conditions ranging from dermatitis, psoriasis, acne and the like.
Past therapies and topicals used to deal with scarring and conditions such as eczema and psoriasis have included the use of simple emollients. Topical steroids ranging from mild agents such as hydrocortisone (1%) through more potent materials such as clobetasol propionate (0.05%) have been used with the common inflammatory dermatoses. In addition, corticosteroids and immunosuppresents have been used to treat skin conditions. Vitamin D and its derivatives such as calcipotrial and tacolcitol and vitamin A and other retinoids have been used to treat dermatological problems. The vitamin D materials are used to treat acne.
For example, U.S. Pat. No. 7,241,451 to Edell describes a scar appearance reducing topical cream comprising: dimethicone copolyol, zinc PEG-30 dipolyhydroxystearate, vitamin D and onion extract.
Biocorneum is a scar cream that is composed solely of silicone cream and SPF 30 that has been shown to improve scars. A recent peer reviewed medical article showed that hyaluronic acid sponge with vitamin C improved the quality of scars. (A Clinical Evaluation of Efficacy and Safety of Hyaluronan Sponge with Vitamin C Versus Placebo for Scar Reduction. Amirlak B, Mahedia M, Shah N. Plast Reconstr Surg Glob Open. 2016 Jul. 11; 4(7):e792.) Studies have also been published in peer-reviewed medical journals.
Other vitamin treatment such as vitamin E have been used to decrease the collagen bonding during the wound healing process and to soften scars. Cutting vitamin E gelatin capsules in half and squeezing out the oil has been the most common way to apply vitamin E to wounds. However, vitamin E oil is messy and cutting the capsules in half is a tedious process. The addition of vitamins A and E in creams and lotions is also known, but such creams and lotions are often oily to the touch and do not dry so as to remain in an oily condition, or they take a long period of time to rub completely into the skin.
Furthermore, past therapies have also included silicone based wound dressings. For example, U.S. Pat. No. 5,741,509 to Berlat describes a wound dressing consisting of at least one non-volatile silicone fluid in admixture with fumed silica, one or more antibacterial active agent and at least one volatile diluent. U.S. Pat. No. 6,337,076 to Sudin describes a film-forming such as Collodion, which comprises a solution of pyroxilin (nitrocellulose) in a 25/75 mixture of alcohol and ether, or Flexible Collodion which comprises a mixture of Collodion with camphor and castor oil.
The above-described ad-hoc approaches have their respective limitations and unwanted side effects, however. The above-described emollients must be reapplied often, and the topical steroids found in some therapies have been linked to thinning skin, bruising, rashes and even Cushings Syndrome in extremely cases. Vitamin D materials may pass transdermally and can affect a user's systemic calcium metabolism.
It is clear that there is a need for a topical composition which can improve the condition of cutaneous injuries or conditions, striae, acne and burns, while avoiding the drawbacks of past and current therapies and compositions.